Background: Severe aortic valve stenosis (AS) is the commonest valve disease. Aortic valve replacement (AVR) is primarily indicated when symptoms occur and/or when there is a drop in left ventricular ejection fraction. However, irreversible myocardial damage, such as replacement fibrosis, leads to increased morbidity and mortality despite treatment. Improved patient selection and timely treatment is thus warranted. T1 mapping, a non-invasive method to quantify myocardial fibrosis by cardiac magnetic resonance (CMR), could be a marker to guide treatment. Aims: To investigate the change of myocardial fibrosis\* in AS patients following AVR and if these changes are associated with disease and/or procedural characteristics. Methods: This is an observational clinical trial. Approximately 60 patients with severe AS planned to undergo AVR (either surgical or transcatheter) at Rigshospitalet, Denmark will be included. Participants will undergo CMR before surgery and at a 1-year follow-up. Other assessments include clinical evaluation and blood sampling. The primary end-point is change in T1 values after AVR. Hypotheses and perspectives: The investigators hypothesize that (1) myocardial fibrosis\* will regress in patients undergoing AVR as a group, (2) the degree of myocardial fibrosis is positively correlated with the degree of symptoms, (3) the regression of myocardial fibrosis is greater in patients undergoing TAVR compared to SAVR, and (4) the regression of myocardial fibrosis is greater in patients with tricuspid aortic stenosis compared to bicuspid aortic stenosis. Ultimately, T1 mapping is a potential marker for improved patient selection for the timing of AVR. \* Estimated by T1 mapping
Study Type
OBSERVATIONAL
Enrollment
86
SAVR or TAVR
Rigshospitalet
Copenhagen O, Denmark
Change in T1 values from baseline to follow-up
Time frame: Through study completion, an average of 1 year
New York Heart Association (NYHA) Classification
Time frame: Through study completion, an average of 1 year
Type of AVR
SAVR or TAVR
Time frame: Through study completion, an average of 1 year
Native valve
Bicuspid or tricuspid aortic valve
Time frame: Through study completion, an average of 1 year
Left ventricular volumes
By cardiac magnetic resonance
Time frame: Through study completion, an average of 1 year
Left ventricular mass
By cardiac magnetic resonance
Time frame: Through study completion, an average of 1 year
Left ventricular strain
By cardiac magnetic resonance and echocardiography
Time frame: Through study completion, an average of 1 year
Late gadolinium enhancement
By cardiac magnetic resonance
Time frame: Through study completion, an average of 1 year
Extracellular volume
By cardiac magnetic resonance
Time frame: Through study completion, an average of 1 year
Left ventricular ejection fraction
By cardiac magnetic resonance and echocardiography
Time frame: Through study completion, an average of 1 year
Left atrial size
By cardiac magnetic resonance and echocardiography
Time frame: Through study completion, an average of 1 year
e' velocity
By echocardiography
Time frame: Through study completion, an average of 1 year
E/e' ratio
By echocardiography
Time frame: Through study completion, an average of 1 year
Tricuspid regurgitation velocity
By echocardiography
Time frame: Through study completion, an average of 1 year
Concentration of NT-Pro-BNP
Time frame: Through study completion, an average of 1 year
Concentration of Troponin T
Time frame: Through study completion, an average of 1 year
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